Alla studier
RekryteringNAINTERVENTIONELL

Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

This study is for people with desmoid tumours that have started to grow or cause symptoms after a period of watchful waiting. Usually, if your tumour grows, you might be given medication, like chemotherapy. This study compares that medical treatment with a procedure called cryoablation, which uses extreme cold to destroy the tumour. Researchers want to find out which treatment is more effective for these types of growing tumours. Patients in the study might get one treatment first, and if needed, they could switch to the other. This helps make sure everyone has access to cryoablation if it's the right choice for them.

Överblick

Status
Rekrytering
Fas
NA
Sponsor
Universitetssjukhuset, Strasbourg, Frankrike
Inskrivningsmål
150
Starta
04 mars 2024
Beräknad slutförande
01 jun 2029

Vad handlar denna studie om?

When someone is first diagnosed with a desmoid tumour, doctors often suggest a 'wait and see' approach. This means they monitor the tumour closely to see if it grows or causes problems, rather than treating it straight away. If the tumour does start to grow or causes symptoms, doctors usually recommend medicines, which can include certain types of chemotherapy.

This study, however, is looking into another treatment option called cryoablation. This procedure uses very cold temperatures to freeze and destroy the tumour. Cryoablation has already shown promise in treating larger desmoid tumours that are growing or causing symptoms. The main goal of this study is to compare cryoablation with the usual medical treatments to see which is more effective when a desmoid tumour starts to progress after the initial 'wait and see' period.

Being part of this study means you would be randomly assigned to either receive cryoablation or medical therapy. The good news is that the study design allows for a 'cross-over'. This means if the first treatment isn't working as well as hoped, or if it becomes necessary, you might be able to switch to the other treatment. This ensures that all patients potentially benefit from cryoablation if it's found to be helpful.

Viktiga punkter

  • Compares freezing tumours (cryoablation) with medicine.
  • For desmoid tumours growing after 'wait and see'.
  • Patients aged 13 and older can take part.
  • Opportunity to receive cryoablation if it's the right choice.
  • Close monitoring of your tumour's progress.

Vem kan vara berättigad?

This study is looking for volunteers who are at least 13 years old and have a desmoid tumour that is not inside the tummy area (extra-peritoneal). We need to have a clear diagnosis of your tumour from a recent biopsy.

Your tumour must have started to grow or cause more symptoms after a period where doctors were just watching it. It also needs to be easily reached by the special tools used for cryoablation, and the doctors must be confident they can remove 100% of it using this method, even if it takes more than one try. You should also be generally well, able to carry out your normal daily activities, and have healthy blood test results.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Are you 13 years old or older?
  2. Do you have a desmoid tumour not in your tummy area?
  3. Has your tumour grown or caused more symptoms recently?
  4. Is your tumour in a place where it can be frozen safely?
  5. Are your general health and blood tests good?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

The specific details of your participation, such as how many visits you'll need, what assessments will be done, and the total duration, are not fully described in this summary. However, you would be randomly assigned to either receive cryoablation or medical therapy. Cryoablation is a procedure, so it would involve appointments for the treatment itself. Medical therapy would involve taking medication, likely with regular check-ups to monitor its effects. There would be imaging scans, like MRI, to keep track of your tumour's size and to see how well the treatment is working. You will have regular checks of your health and blood tests. You'll need to use reliable contraception if you're a woman who could become pregnant. The study aims to follow your progress and the effect of the treatment over time.

Potentiella risker och fördelar

Taking part in this study may offer potential benefits, such as access to cryoablation, which has shown promise for certain desmoid tumours, or receiving standard medical therapy under close monitoring. However, there are also potential risks associated with any medical treatment, including side effects from medication or complications from the cryoablation procedure. The study team will explain these risks in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Platser (13)

  • Service d'oncologie/CHU de Besançon
    Verifierat postnummer
    Besançon, France· Rekryterar inte ännu
  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
    Verifierat postnummer
    Bordeaux, Frankrike· Rekrytering
  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
    Verifierat postnummer
    Caen, Frankrike· Rekrytering
  • Service d'Oncologie Médicale -Centre Georges François LECLERC
    Verifierat postnummer
    Dijon, Frankrike· Rekrytering
  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD
    Verifierat postnummer
    Lyon, Frankrike· Rekrytering
  • Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone
    Verifierat postnummer
    Marseille, Frankrike· Rekrytering
  • Service de Radiologie-CHU de Nantes
    Verifierat postnummer
    Nantes, Frankrike· Rekrytering
  • Service d'Oncologie Médicale-Centre Antoine LACASSAGNE
    Verifierat postnummer
    Nice, Frankrike· Rekrytering
  • Service d'Oncologie Médicale
    Verifierat postnummer
    Saint-Herblain, Frankrike· Rekrytering
  • Institut de cancérologie Strasbourg Europe (ICANS)
    Verifierat postnummer
    Strasbourg, Frankrike· Rekrytering
  • Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091
    Verifierat postnummer
    Strasbourg, Frankrike· Rekrytering
  • Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse
    Verifierat postnummer
    Toulouse, Frankrike· Rekryterar inte ännu

Vanliga frågor

What is a desmoid tumour?

It's a rare type of growth that is not cancer but can grow into nearby tissues and sometimes causes pain or problems.

Vad är 'vaksam väntan'?

This means doctors will carefully monitor your tumour to see if it changes or grows before suggesting active treatment.

What is cryoablation?

It's a procedure that uses very cold temperatures to freeze and destroy the tumour.

Will I definitely get cryoablation in this study?

You might get cryoablation or medical therapy. The study design allows you to switch to cryoablation later if needed.

Kan barn delta i denna studie?

Yes, individuals aged 13 and older can take part if they meet the other study requirements.

Hur du får reda på mer

Afshin GANGI, MD,PhD

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

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